Effect of Transcutaneous Electrical Nerve Stimulation in Tinnitus - An Academic Study

Tinnitus is the perception of a sound in the absence of external sound stimulation. Subjective tinnitus is defined as the perception of a sound in the absence of any external vibratory stimulation  The reactions to tinnitus have been classified into four primary functions of daily living activities: emotions, hearing, sleep and concentrations . Tinnitus may result in anxiety, depression, insomnia, and poor quality of life in patients. Noting the mechanisms producing tinnitus , neuromodulation is being attempted to hamper the neural pathways producing tinnitus . The mechanism involves activation of the nucleus of the solitary tract, which in turn activates the locus coeruleus and nucleus basalis, which then releases neuromodulators that have effects on plasticity regulation by modulating the neurons in the cortex . As tinnitus is associated with an imbalance between excitation and inhibition that may lead to map reorganization and increased synchronous firing of auditory neurons , neuromodulation by vagal nerve stimulation might have a positive influence on this process. In this study we aim to study the effect of transcutaneous electrical nerve stimulation in reducing the subjective tinnitus. Population of study is those patients with subjective tinnitus meeting our inclusion criteria. It will take place in the ENT OPD of our hospital It is a triple blinded randomized control trial. Patients between 18 to 65 years suffering from perception of tinnitus for a minimum period of 3 months would be included in our study .History taking and physical examination will be done followed by relevant investigations . Patients with objective tinnitus will be excluded from the study Patients consent will be taken. Patients with tinnitus will be randomly allocated to the verum TENS group and sham TENS group in a 1:1 ratio. Patients would complete questionnaires including the visual analog scale (VAS) , Tinnitus Handicap Inventory (THI). Total of 30 patients in the treatment arm ( electrical stimulation / verum arm ) would be subjected to TENS twice a week for a period of 4 weeks . For the sham stimulation group - 30 , the treatment paradigm would be identical to the electrical stimulation group except that the power supply would be turned off and current would not be delivered from the probe. Even in the electrical stimulation group, patients would not be able to feel sound vibrations or sense current delivery. Patients would thus be unaware of the treatment group to which they are assigned. THI and VAS that were administered to the patients at the beginning of the study would be given again and responses would be noted after every session , one monthly , 3 monthly and 6 monthly intervals either in person or in a telephonic format . Thus patients would be followed up over a period of 6 months .